Please contact Prem Nichani for a copy of the Abstract as it is neither officially accepted nor published by a scholarly journal or academic conference.

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Abstract

Topic: Retina

Purpose: Intravitreal injections (IVI) of anti-vascular endothelial growth factor (anti-VEGF) agents are pivotal in the treatment armamentarium of neovascular retinal diseases. Treat-and-extend (T&E) dosing aims to reduce cost barriers and the burden of frequent injections; however, the efficacy and safety of T&E versus other dosing regimens remains unclear. This meta-analysis comprehensively consolidates the data from published randomized clinical trials (RCTs) to answer this clinically relevant question.

Study design: Systematic review and meta-analysis.

Methods: We conducted a systematic literature search of Ovid MEDLINE, EMBASE, and Cochrane CENTRAL to September 2020. English-language RCTs reporting on efficacy and/or safety outcomes of T&E, bimonthly, monthly, and/or pro re nata (PRN) dosing regimens of anti-VEGF IVIs were included. Critical appraisal of trials for risk of bias and strength of evidence was performed using the Cochrane and GRADE guidelines, respectively. The primary outcome was improvement in best-corrected visual acuity (BCVA), while secondary outcomes included changes in central subfield thickness (CSFT), mean number of injections, mean number of follow-up visits, and incidence of adverse events. All outcomes were collected at last follow-up. Meta-analyses were conducted using a random effects model. If data were available, subgroup analyses were performed based on IVI agent and retinal disease.

Results: Across 11 included RCTs, 1140 eyes were treated with a T&E IVI dosing regimen, 866 with monthly, 123 with bimonthly, and 253 with PRN-dosed IVIs. One of 11 trials had a target follow-up of 6 months, five of 12 months, and five of 24 months (mean: 16.4 ± 7.0 months per eye). Across all trials, risk of bias was generally low-to-moderate. Mean change in BCVA and CSFT at last follow-up were non-significantly different between T&E versus monthly (P = 0.23 and 0.22, respectively), bimonthly (P = 0.88 and 0.18, respectively), and PRN (P = 0.30 and 0.54, respectively) dosing regimens. T&E conferred significantly fewer injections versus monthly (P < 0.001) but significantly higher injections versus PRN (P < 0.001) dosing regimens by final follow-up. There was no significant difference in safety outcomes amongst comparators.

Conclusions: Efficacy and safety differences are non-significant between T&E, bimonthly, monthly, and PRN regimens. T&E confers a statistically significant benefit of reduced injection burden relative to monthly dosing and reduced clinic visits relative to PRN. T&E remains efficacious while potentially enhancing patient satisfaction, improving treatment adherence, stabilizing visual function, conferring cost savings, and aiding in capacity planning to treat neovascular retinal disease.

Presentations

1. Nichani P, Popovic MM, Dhoot AS, Pathak A, Muni RH, Kertes PJ. (2021). Comparison of treat-and-extend to monthly and as-needed dosing of intravitreal anti-vascular endothelial growth factor agents: A meta-analysis of randomized controlled trials. Canadian Ophthalmological Society Annual Meeting & Exhibition, Virtual Meeting (ePoster). View presentation, references, and conflicts of interest here.

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Please contact Prem Nichani for a copy of the Abstract as it is not officially accepted by nor published in a scholarly journal. Currently under review at Ophthalmology Retina.

Presentations

1. Popovic MM, Nichani P, Dhoot AS, Pathak A, Muni RH, Kertes PJ. (2021). Treat-and-extend dosing of intravitreal anti-VEGF agents in neovascular age-related macular degeneration: A meta-analysis of 1697 eyes. UofT Department of Ophthalmology & Vision Sciences 62nd Research Day, Toronto, Ontario, Canada (ePoster). View presentation, references, and conflicts of interest here.

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Purpose: This meta-analysis aimed to investigate the efficacy and safety of pars plana vitrectomy (PPV), scleral buckle (SB), and pneumatic retinopexy (PR) for the management of rhegmatogenous retinal detachments (RRDs).

Setting: Meta-analysis.

Methods: A systematic literature search was performed on Ovid MEDLINE, EMBASE and Cochrane CENTRAL from inception to July 2019. Randomized controlled trials (RCTs) comparing RRD management options were included. Outcomes were reported via risk ratios (RR) for categorical variables and weighted mean differences (WMD) for continuous parameters with 95% confidence intervals (95%CI). Risk of bias assessment was conducted using the Cochrane criteria and a random-effects model was used for analysis. The visual recovery and incidence of complications were primary endpoints, while primary reattachment rate was a secondary outcome.

Results: Sixteen RCTs and 2613 eyes were included. For PPV versus SB, early postoperative visual acuity favoured SB (weighted mean less than 1 month postoperatively: ~20/1000 for PPV versus ~20/160 for SB, p=0.03), but differences between groups were non-significant at other timepoints (e.g. 12+ months: ~20/60 for PPV and ~20/70 for SB). There was no difference between PPV and SB for primary reattachment (RR=1.05, 95%CI=[0.98,1.14], p=0.16). PPV was associated with a lower rate of choroidal detachment (RR=0.19, 95%CI=[0.06,0.60], p=0.004, NNT=11), hypotony (RR=0.08, 95%CI=[0.01,0.61], p=0.01, NNT=4) and strabismus/diplopia (RR=0.17, 95%CI=[0.03,0.96], p=0.04, NNT=25) relative to SB, while SB was associated with a lower incidence of iatrogenic breaks (RR=12.02, 95%CI=[2.31,62.55], p=0.003). Combination management was non-significantly different relative to PPV or SB alone for final CDVA, complications and reattachment rate. One trial comparing PR and PPV showed superior visual recovery and final acuity, less vertical metamorphopsia and reduced morbidity following PR.

Conclusions: PPV is associated with a slower visual recovery and less morbidity but similar final visual acuity and primary reattachment rate relative to SB. Combination procedures did not improve primary reattachment rates or vision and were associated with comparable safety outcomes. Emerging data suggests that, in certain primary RRDs, PR should be a first-line intervention over PPV.

Presentations

1. Popovic MM, Muni RH, Nichani P, Kertes PJ. (Oct 2020). Pars plana vitrectomy, scleral buckle, pneumatic retinopexy and combination procedures for the management of rhegmatogenous retinal detachment: A meta-analysis. European Society of Retina Specialists EURetina, Virtual Meeting (oral). View presentation here.

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Presentations

1. Nichani P, Popovic MM, Muni RH, Mireskandari K, Tehrani NN, Kertes PJ. (2020). Intravitreal injections versus laser photocoagulation for retinopathy of prematurity: A meta-analysis of 3701 eyes. American Academy of Ophthalmology, Las Vegas, NV, United States (ePoster). Spotlighted by OphthalmologyAdvisor.com and PracticeUpdate.com. View ePoster with narration here.
2. Popovic MM, Nichani P, Muni RH, Mireskandari K, Tehrani NN, Kertes PJ. (2020). Intravitreal injections versus laser photocoagulation for retinopathy of prematurity: A meta-analysis of 3701 eyes. European Society of Retina Specialists EURetina, Virtual Meeting (oral). View presentation here.
3. Popovic MM, Nichani P, Muni RH, Mireskandari K, Tehrani NN, Kertes PJ. (2020). Intravitreal injections versus laser photocoagulation for retinopathy of prematurity: A meta-analysis of 3701 eyes. UofT Department of Ophthalmology & Vision Sciences 62nd Research Day, Toronto, ON (oral). Alumni Award for Best Resident Research Presentation. View presentation here.

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Abstract

Topic: The role of topical nonsteroidal anti-inflammatory drugs (NSAIDs) for the reduction of ocular pain after intravitreal injections (IVIs) has been explored. To provide clarity on the evidence for these agents, the present meta-analysis of randomized controlled trials (RCTs) was undertaken.

1. Popovic MM, Muni RH, Nichani P, Kertes PJ. (Oct 2020). Topical non-steroid anti-inflammatory drugs for pain from intravitreal injections: A meta-analysis. European Society of Retina Specialists EURetina, Virtual Meeting (ePoster). View ePoster here.

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1. Micieli JA, Nichani P. (2020). Granuloma annulare, scalp necrosis, and ischemic optic neuropathy from giant cell arteritis after varicella-zoster virus vaccination. Canadian Ophthalmological Society Annual Meeting & Exhibition, Vancouver, BC (ePoster).

Notes

COS2020 Reference List:

1. Hoffman GS. Giant cell arteritis. Ann Int Med. 2016;165:ITC65-80.
2. Weyand CM, Goronzy JJ. Giant-cell arteritis and polymyalgia rheumatica. N Engl J Med. 2014;37:50–7.
3. Devaraj NK. Giant cell arteritis: where did we go wrong? Fortune J Rheumatol. 2019;1:12-4.
4. Weyand CM, Liao YJ, Goronzy JJ. The immunopathology of giant cell arteritis: diagnostic and therapeutic implications. J Neuroophthalmol. 2012;32:259–265.
5. Helweg-Larsen J, Tarp B, Obel N, Baslund B. No evidence of parvovirus B19, Chlamydia pneumoniae or human herpes virus infection in temporal artery biopsies in patients with giant cell arteritis. Rheumatol (Oxford). 2002;41:445–9.
6. Ing EB, Ing R, Liu X, Zhang A, Torun N, et al. Does herpes zoster predispose to giant cell arteritis: a geo-epidemiologic study. Clin Ophthalmol. 2018;12:113–118.
7. Lotan I, Steiner I. Giant cell arteritis following varicella zoster vaccination. J Neurol Sci. 2017;375:158–9.
8. Gilden D, White T, Khmeleva N, Heintzman A, Choe A, et al. Prevalence and distribution of VZV in temporal arteries of patients with giant cell arteritis. Neurology. 2015;85:1914–5.
9. Nagel MA, White T, Khmeleva N, Rempel A, Boyer PJ, et al. Analysis of varicella-zoster virus in temporal arteries biopsy positive and negative for giant cell arteritis. JAMA Neurol. 2015;72:1281–7.
10. Perez C, Loza E, Tinture T. Giant cell arteritis after influenza vaccination. Arch Intern Med. 2000;160:2677.
11. Shoenfeld Y, Agmon-Levin N. “ASIA”—autoimmune/ inflammatory syndrome induced by adjuvants. J Autoimmun. 2011;36:4–8.
12. Torisu Y, Horai Y, Michitsuji T, Kawahara C, Mori T, et al. Giant cell arteritis with generalized granuloma annulare. Intern Med. 2019;58:1173–1177.
13. Fukai K, Ishii M, Kobayashi H, Someda Y, Hamada T, et al. Generalized granuloma annulare in a patient with temporal arteritis: are these conditions associated? Clin Exp Dermatol. 1990;15:70–2.
14. Kluger N, Riviere S, Mura M, Guillot B, Girard C. Simultaneous occurrence of generalized granuloma annulare, anterior uveitis and giant cell arteritis: coincidental or not? Presse Med. 2012;41:548–9.
15. Yanez S, Val-Bernal JF, Pena-Sagredo JL. Granuloma annulare and giant cell arteritis. Clin Exp Rheumatol. 2008;3:S108–10.
16. Günes ̧ P, Göktay F, Mansur AT, Köker F, Erfan G. Collagen-elastic tissue changes and vascular involvement in granuloma annulare: a review of 35 cases. J Cutan Pathol. 2009;36:838–44.

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1. Nichani P, Micieli JA. (Jun 2020). Retinal manifestations of idiopathic intracranial hypertension. Canadian Ophthalmological Society Annual Meeting & Exhibition, Virtual Meeting (oral). View presentation here.

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A 31-year-old healthy Asian man presented with new headaches and blurred vision. He was found to have bilateral optic disc edema (ODE) and peripapillary subretinal fluid and was initially investigated for causes of raised intracranial pressure. After referral to neuro-ophthalmology, he received a diagnosis of Vogt–Koyanagi–Harada (VKH) disease and his symptoms, ODE, and vision improved promptly with prednisone treatment. HLA typing was performed and returned positive for the HLA-DRB1*04 subtype. Although VKH disease usually presents with granulomatous uveitis or serous retinal detachments, ODE may manifest early in the disease course. Those with ODE in VKH disease are believed to be older and female, but this case demonstrates that these findings were also seen in a young man.

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Purpose: Micro-invasive glaucoma surgery (MIGS) is a less traumatic and potentially safer surgical method for patients with open-angle glaucoma. However, it is a recent development for which the high-quality literature must be evaluated.

Study design: Systematic review.

Methods: A review of MIGS was conducted by searching Ovid MEDLINE, EMBASE, and Cochrane CENTRAL (2006 to 2019). The primary efficacy indicators were reductions in intraocular pressure (IOP) and topical medication use postoperatively. Adverse event analysis was conducted; risk of bias assessment was performed using the Cochrane, Newcastle-Ottawa, and World Glaucoma Association recommendations.

Results: From 10076 articles identified, 3476 baseline eyes across 20 trials met all eligibility criteria and were included. The mean age was 69.5 ± 2.9, 53.7% were female, 77.4% were Caucasian, and 80% of included studies were randomized controlled trials. One study had last follow-up at less than one year, fifteen studies had follow-up extending 1-2 years, and four had longer than two years of follow-up. MIGS procedures or devices assessed included ab interno canaloplasty (ABiC), cyclophotocoagulation (CPC), CyPass^® Micro-Stent, excimer laser trabeculotomy (ELT), Hydrus^® Microstent, iStent^® (1^st generation), iStent^® inject (2^nd generaton), Kahook Dual Blade^®, micropulse (MDLT), Trabectome^®, and XEN^® Gel Stent. A pattern of more significant IOP and medication reduction was observed in patients who received a MIGS device relative to control intervention. Across all studies at last follow-up, the mean IOP reduction was 8.0 ± 2.2 mmHg (n = 2067; range: 2.4–16.5 mmHg) vs. 7.1 ± 3.3 mmHg (n = 1234; range: 1.7–16 mmHg) and the mean reduction of topical medications was 1.4 ± 0.4 (n = 1864; range: -0.2–3 mmHg) vs. 1.0 ± 0.7 (n = 1234; range: -1–3 mmHg) in MIGS vs. control eyes, respectively. The 1^st generation iStent had the most literature supporting its efficacy, followed by the Hydrus. Adverse events were more common among phaco-only eyes (42.3%) vs. standalone-MIGS eyes (21.9%); the rate was 45.0% for phaco-MIGS eyes. The most common adverse events following MIGS implantation included stent obstruction, inflammation, and repeat surgical intervention.

Conclusions: Overall, there is some evidence to support the role of trabecular bypass and suprachoroidal MIGS devices in the treatment armamentarium for glaucoma. MIGS can effectively reduce IOP, decrease the number of topical medications taken, and minimize the number of complications associated with more invasive surgical devices, thus improving quality of life. We await the upcoming RCT evidence from other MIGS devices including the XEN^® Gel Stent and InnFocus MicroShunt and hope through this iterative process to elucidate the comparative efficacy, safety, and future role of MIGS in the glaucoma surgical paradigm.

Keywords: MIGS; ocular drainage implant; glaucoma surgery; filtration surgery; open-angle glaucoma; IOP reduction

Presentations

1. Nichani P, Popovic M, Schlenker MB, Park J, Ahmed IIK. (2020). Micro-invasive glaucoma surgery: A selected review of studies. Canadian Ophthalmological Society Annual Meeting & Exhibition, Virtual Meeting (ePoster). 2^nd Place Poster Award. View presentation, references, and conflicts of interest here.
2. Nichani P, Popovic M, Schlenker MB, Park J, Ahmed IIK. (2020). Micro-invasive glaucoma surgery: A selected review of studies. UofT Department of Ophthalmology & Vision Sciences 62nd Research Day, Toronto, Ontario, Canada (oral). View presentation, references, and conflicts of interest here.

Notes

Studies Included in Analysis:

1. Ab Interno Canaloplasty (ABiC)
   • Gandolfi; J Ophthalmol. 2016;2016:3410469 .
2. Micropulse Cyclophotocoagulation (CPC)
   • Aquino; Clin Exp Ophthalmol. 2015;43(1):40-6. (NCT00349414)
3. CyPass® Micro-Stent
   • Vold; Ophthalmology. 2016;123(10):2103-12. (NCT01085357)
4. Excimer Laser Trabeculectomy
   • Babighian; Eye. 2010;24(4):632-8.
5. Hydrus® Microstent
   • Samuelson; Ophthalmology. 2019;126(1):29-37. (NCT01539239)
   • Pfeiffer; Ophthalmology. 2015;122(7):1283-93. (NCT01818115)
6. Hydrus® Microstent vs. iStent®
   • Ahmed; Ophthalmology. 2019:1-10. (NCT02023242)
7. iStent® (G1) and iStent® Inject (G2)
   • Samuelson; Ophthalmology. 2019;126(6):811-21. (NCT00323284)
   • Katz; Clin Ophthalmol. 2018;12:255-62. (NCT01517477)
   • Vold; Ophthalmol Ther. 2016;5(2):161-72. (NCT01443988)
   • Fea; Clin Ophthalmol. 2014;8:875-82.
   • Samuelson; Ophthalmology. 2011;118(3):459-67. (NCT00323284)
   • Fernández-Barrientos; Invest Ophthalmol Vis Sci. 2010;51(7):3327-32. (NCT00326066)
8. Kahook Dual Blade® (KDB)
   • Le; Adv Ther. 2019;36(9):2515-27.
9. Micropulse Diode Laser Trabeculoplasty (MDLT)
   • Detry-Morel; Bull Soc Belge Ophtalmol. 2008;(308):21-8.
10. Trabectome®
    • Sato; BMJ Open Ophthalmol. 2018;3(1):1-7. (UMIN000021170)
    • Ting; Can J Ophthalmol. 2018;53(6):588-94. (NCT00901108)
11. XEN® Gel Stent
    • Schlenker; Ophthalmology. 2017;124(11):1579-88.

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